ViraCor Laboratories Is First National Reference Laboratory To Offer Novel Respiratory Viral Testing
KANSAS CITY, Missouri – January 4, 2008 -- ViraCor Laboratories, a specialty molecular diagnostic reference laboratory, is the first national reference laboratory to offer the xTAG™ Respiratory Viral Panel (RVP) from Luminex Corporation (Nasdaq: LMNX), which yesterday received 510(K) clearance from the Food and Drug Administration (FDA). xTAG RVP is a novel molecular diagnostic product that detects 12 major respiratory viruses and subtypes simultaneously, from one patient sample. ViraCor was selected by Luminex to be an early adopter reference laboratory for the assay.
xTAG RVP will provide clinicians rapid access to definitive and accurate results that will improve treatment choices, infection control and public health surveillance of respiratory viruses, from the common cold to adenovirus. It is the first multiplexed nucleic acid test for respiratory viruses cleared for in vitro diagnostic use by the FDA.
“xTAG RVP is a major advancement in respiratory viral testing because it gives doctors fast and accurate results for the nation’s most important respiratory viruses. Up until now, clinicians have been playing a guessing game based largely on a patient’s symptoms,” said Steve Kleiboeker, Ph.D., Vice President and Chief Scientific Officer of ViraCor Laboratories. “The high degree of sensitivity and specificity of xTAG RVP helps eliminate incorrect diagnosis by greatly reducing the false negative results that are common with conventional testing methods.”
xTAG RVP is a highly sensitive molecular assay able to pinpoint several respiratory viruses that are not currently detected by conventional methods, including human metapneumovirus (hMPV), rhinovirus and influenza A subtypes H1 and H3. The assay’s ability to detect hMPV and rhinovirus is particularly important as these two viruses represent the cause of in excess of 40 percent of respiratory viral infections and were previously difficult for laboratories to detect.
“We are extremely proud to offer the xTAG RVP assay immediately following FDA clearance and just in time for the flu season,” said John Martin, President of ViraCor Laboratories. “This groundbreaking assay, coupled with our 24-hour turnaround time, will greatly improve a doctor’s ability to provide the best patient care possible, as well as a cost-effective solution to respiratory virus testing.”
Clinicians currently rely on slower and less accurate methods to assist in the diagnosis of respiratory infections. These methods often result in missed infections or misdiagnosis and contribute to the overuse of antibiotics, nosocomial spread, unnecessary medical procedures and prolonged hospital stays, all of which directly add to the burden and costs associated with respiratory infections.
“ViraCor has been a strong proponent of xTAG RVP through the course of its development, and we are very pleased ViraCor has committed to making the test available to clinicians this respiratory season,” said Dr. Jeremy Bridge-Cook, Vice President of Luminex Molecular Diagnostics. “We are confident that ViraCor will provide xTAG RVP customers the same level of excellence, efficiency and customer service that it has made standard with its other molecular assays.”
The 12 viral targets included in the xTAG RVP assay are as follows:
- Influenza A (non-specific subtype)
- Influenza A H1
- Influenza A H3
- Influenza B
- Parainfluenza 1
- Parainfluenza 2
- Parainfluenza 3
- Respiratory syncytial virus (RSV) A
- Respiratory syncytial virus (RSV) B
ABOUT VIRACOR LABORATORIES
ViraCor Laboratories is a leading molecular diagnostic and research laboratory dedicated to providing innovative diagnostic testing to the critical care and immunocompromised patient population, with expertise in infectious diseases including viruses, protozoa and fungi. The company set the standard for the diagnostic industry by turning all patient results around in 24 hours, unlike traditional lab results which can take three days to several weeks. The company is a trusted partner of transplant hospitals nationwide, including 60% of all pediatric transplant hospitals.